Themo-Flo System 3 Laparoscopic/Hysteroscopic System
FDA 510(k) K941507 · Sanese Medical Corp.
510(k) numberK941507
Submission
- Device name
- Themo-Flo System 3 Laparoscopic/Hysteroscopic System
- Applicant
- Sanese Medical Corp.
Columbus, OH, US - Received
- March 29, 1994
- Decision date
- March 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HET
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|---|---|---|---|
| K250939 | SIRIUS Endoscope System (PR-SI-1230)HET · Traditional | Precision Robotics (Hong Kong) Limited | 08/29/2025SE |
| K243821 | i-CutHET · Traditional | A.M.I. Agency For Medical Innovations GmbH | 04/25/2025SE |
| K221642 | SIRIUS Endoscope SystemHET · Traditional | Precision Robotics (Hong Kong) Limited | 12/12/2022SE |
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| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5HET · Traditional | Olympus Medical Systems Corp. | 09/17/2021SE |
| K210104 | SurroundScope SystemHET · Traditional | 270surgical , Ltd. | 07/08/2021SE |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…HET · Traditional | Schoelly Fiberoptic GmbH | 03/12/2021SE |
| K200216 | 4K UHD Camera SystemHET · Traditional | Scivita Medical Technology Co., Ltd. | 08/21/2020SE |
| K200638 | LAP-iX Suction IrrigationHET · Special | Sejong Medical Co., Ltd. | 04/03/2020SE |
| K190190 | WV1 EndoscopeHET · Traditional | 270surgical , Ltd. | 11/01/2019SE |
Questions and answers
When was Themo-Flo System 3 Laparoscopic/Hysteroscopic System cleared by the FDA?
Themo-Flo System 3 Laparoscopic/Hysteroscopic System (K941507) received a 510(k) decision of Substantially Equivalent on March 6, 1995, 342 days after the submission was received.
What is the product code of K941507?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.